Plaque PsoriasisPhase 1/2NCT04172233
A Clinical Study of AK101 in Subjects With Moderate to Severe Plaque Psoriasis
A Phase 1/2 study testing AK101 in people with Plaque Psoriasis, run by Akeso at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and the preliminary efficacy of AK101，an anti-IL-12/23p40 monoclonal antibody, when administered subcutaneously in subjects with moderate-to-severe plaque psoriasis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- AK101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 9 Jan 2018to 31 Oct 2019
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have had Plaque Psoriasis diagnosed at least 6 months prior to screening.
- Clinical diagnosis of stable plaque psoriasis with involvement of ≥ 10% body surface area. Psoriasis area and severity index(PASI) ≥12. Physicians Global Assessment score ≥3.
- Patients who have received systemic therapy or phototherapy, or who have been allowed by the investigator to receive systemic therapy or phototherapy.
- Women of childbearing potential should not be in pregnancy or lactation, men and women of childbearing potential must agree to use adequate birth control measures during study participation and for 6 months after the last dose of study treatment.
- Ability to provide written informed consent and to be compliant with the schedule of protocol assessments.
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures as specified in the protocol.
Who cannot join
- Had nonplaque forms of psoriasis (e.g., Guttate, erythrodermic, or pustular).
- Had other active skin diseases or skin infections (e.g., bacterial, fungal or viral infection) that could affect psoriasis evaluation.
- Had Imaging diagnosis of pulmonary infection or fibrosis during the 3 months prior to screening.
- History or evidence of active or latent tuberculosis at screening.
- Serious systemic infections or local infections during the 2 months prior to screening.
- History of cancer, including solid tumors and hematological malignancies (except basal cell and in situ squamous cell carcinomas of the skin that have been excised and resolved).
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- Known allergy or hypersensitivity to any biologic therapy at screening that would pose an unacceptable risk to the subject if participating in this study.
- History of alcohol or drug abuse.
- History or known presence of recurrent or chronic infection (e.g., hepatitis B, or C, human immunodeficiency virus [HIV], syphilis, TB).
- Had received any DMARDs (e.g., anti-malaria drug, retinoids, interferon, lithium) during 2 weeks prior to screening.
- Had received any physical therapy (e.g., PUVA, ultra-violet therapy, tanning beds) during 2 weeks prior to screening.
- Had received any systemic psoriasis therapy (e.g., glucocorticoid, retinoids, ciclosporin, methotrexate, or tripterygium) during 4 weeks prior to screening.
- Had Enrolled in any other trials during 3 months prior to screening or concurrently enrolled in any other trials.
- Had received previous treatment with any anti-IL-12/IL-23, IL-12, IL-23, IL-17 therapy for the treatment of psoriasis or psoriatic arthritis.
- Had received previous treatment with natalizumab or any other drugs that regulate B cells or T cells (rituximab, abatacept, alemtuzumab) during 12 months prior to screening.
- Had received other biologic therapy (e.g., TNF inhibitor) during 6 months prior to screening.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
Official title: A Randomized, Double-blinded, and Placebo-controlled Phase I/II Clinical Study of AK101 in Subjects With Moderate to Severe Plaque Psoriasis
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and the preliminary efficacy of AK101，an anti-IL-12/23p40 monoclonal antibody, when administered subcutaneously in subjects with moderate-to-severe plaque psoriasis.
Read the detailed description
This was a single-center, randomized, double-blind, placebo-controlled trial which consisted of a dose escalation phase (Phase I) and a dose expansion phase (Phase II)..
- Conditions
- Plaque Psoriasis
- Being tested
- AK101, placebo
- Keywords
- IL12/23
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK101Biological
AK101 is an anti-IL-12/23p40 monoclonal antibody.
placeboBiological
matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Phase I: AK101 45 mg | Experimental | Biological: AK101 AK101 45 mg on Week 0 and 4 by subcutaneous injection Receives: Biological: AK101 |
| Phase I: AK101 135 mg | Experimental | Biological: AK101 AK101 135 mg on Week 0 and 4 by subcutaneous injection Receives: Biological: AK101 |
| Phase I: AK101 270 mg | Experimental | Biological: AK101 AK101 270 mg on Week 0 and 4 by subcutaneous injection Receives: Biological: AK101 |
| Phase I: Placebo | Placebo comparator | Biological: Placebo Placebo on Week 0 and 4 by subcutaneous injection Receives: Biological: placebo |
| Phase II: AK101 45 mg | Experimental | Biological: AK101 AK101 45 mg on Week 0, 4 and 16 by subcutaneous injection Receives: Biological: AK101 |
| Phase II: AK101 90 mg | Experimental | Biological: AK101 AK101 90 mg on Week 0, 4 and 16 by subcutaneous injection Receives: Biological: AK101 |
| Phase II: AK101 135 mg | Experimental | Biological: AK101 AK101 135 mg on Week 0, 4 and 16 by subcutaneous injection Receives: Biological: AK101 |
| Phase II: Placebo to AK101 | Placebo comparator | Drug: Placebo Placebo on Week 1 and 4 by subcutaneous injection, and then AK101 on Week 12 16 by subcutaneous injection Receives: Biological: AK101; Biological: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment emergent adverse events (TEAEs)
Measured: From the time of signing informed consent till Week 16 for Phase I or Week 28 for Phase II
Secondary outcomes (7)
Number of participants who achieved ≥ 75% reduction in Psoriasis Area and Severity Index (PASI75)
Measured: At Week 2, 4, 8, 12, 16, 20 (Phase II), 24 (Phase II) and 28 (Phase II)
Number of participants who achieved ≥ 90% reduction in PASI (PASI90)
Measured: At Week 2, 4, 8, 12, 16, 20 (Phase II), 24 (Phase II) and 28 (Phase II)
Change From Baseline in the Physician Global Assessment (PGA)
Measured: At Week 2, 4, 8, 12, 16, 20 (Phase II), 24 (Phase II) and 28 (Phase II)
Number of subjects who develop detectable anti-drug antibodies (ADAs)
The immunogenicity of AK101 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs).
Measured: From first dose till Week 16 for Phase I or Week 28 for Phase II
Area under the curve (AUC) of AK101
The endpoints for assessment of PK of AK101 include serum concentrations of AK101 at different timepoints after AK101 administration.
Measured: From first dose till Week 16 for Phase I
Minimum observed concentration (Cmin) of AK101
The endpoints for assessment of PK of AK101 include serum concentrations of AK101 at different timepoints after AK101 administration.
Measured: From first dose till Week 16 for Phase I or Week 28 for Phase II
Maximum observed concentration (Cmax) of AK101
The endpoints for assessment of PK of AK101 include serum concentrations of AK101 at different timepoints after AK101 administration.
Measured: From first dose till Week 16 for Phase I or Week 28 for Phase II
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start9 Jan 2018
- Primary completion31 Oct 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- More trials run by AkesoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Akeso Tiancheng, Inc
- Responsible party
- Sponsor
- Investigators
- Rui Chen, MD, Principal investigator, Peking Union Medical College HospitalHongzhong Jin, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04172233
- Sponsor's protocol ID
- AK101-101
- Status last verified
- Feb 2025
- First submitted
- 19 Nov 2019
- Last updated
- 3 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blinded, and Placebo-controlled Phase I/II Clinical Study of AK101 in Subjects With Moderate to Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT04172233
- Acronym / sponsor ID
- AK101-101
- Conditions
- Plaque Psoriasis
- Keywords
- IL12/23
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Collaborators
- Akeso Tiancheng, Inc
- Study start
- 9 Jan 2018 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 21 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and the preliminary efficacy of AK101，an anti-IL-12/23p40 monoclonal antibody, when administered subcutaneously in subjects with moderate-to-severe plaque psoriasis.
Detailed description
This was a single-center, randomized, double-blind, placebo-controlled trial which consisted of a dose escalation phase (Phase I) and a dose expansion phase (Phase II)..
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Phase I: AK101 45 mg | Experimental | Biological: AK101Biological: AK101 AK101 45 mg on Week 0 and 4 by subcutaneous injection |
| Phase I: AK101 135 mg | Experimental | Biological: AK101Biological: AK101 AK101 135 mg on Week 0 and 4 by subcutaneous injection |
| Phase I: AK101 270 mg | Experimental | Biological: AK101Biological: AK101 AK101 270 mg on Week 0 and 4 by subcutaneous injection |
| Phase I: Placebo | Placebo comparator | Biological: placeboBiological: Placebo Placebo on Week 0 and 4 by subcutaneous injection |
| Phase II: AK101 45 mg | Experimental | Biological: AK101Biological: AK101 AK101 45 mg on Week 0, 4 and 16 by subcutaneous injection |
| Phase II: AK101 90 mg | Experimental | Biological: AK101Biological: AK101 AK101 90 mg on Week 0, 4 and 16 by subcutaneous injection |
| Phase II: AK101 135 mg | Experimental | Biological: AK101Biological: AK101 AK101 135 mg on Week 0, 4 and 16 by subcutaneous injection |
| Phase II: Placebo to AK101 | Placebo comparator | Biological: AK101, Biological: placeboDrug: Placebo Placebo on Week 1 and 4 by subcutaneous injection, and then AK101 on Week 12 16 by subcutaneous injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Have had Plaque Psoriasis diagnosed at least 6 months prior to screening.
- Clinical diagnosis of stable plaque psoriasis with involvement of ≥ 10% body surface area. Psoriasis area and severity index(PASI) ≥12. Physicians Global Assessment score ≥3.
- Patients who have received systemic therapy or phototherapy, or who have been allowed by the investigator to receive systemic therapy or phototherapy.
- Women of childbearing potential should not be in pregnancy or lactation, men and women of childbearing potential must agree to use adequate birth control measures during study participation and for 6 months after the last dose of study treatment.
- Ability to provide written informed consent and to be compliant with the schedule of protocol assessments.
Key exclusion criteria (16 listed)
- Had nonplaque forms of psoriasis (e.g., Guttate, erythrodermic, or pustular).
- Had other active skin diseases or skin infections (e.g., bacterial, fungal or viral infection) that could affect psoriasis evaluation.
- Had Imaging diagnosis of pulmonary infection or fibrosis during the 3 months prior to screening.
- History or evidence of active or latent tuberculosis at screening.
- Serious systemic infections or local infections during the 2 months prior to screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AK101AK101 is an anti-IL-12/23p40 monoclonal antibody. | Biological | Phase I: AK101 135 mg, Phase I: AK101 270 mg, Phase I: AK101 45 mg, Phase II: AK101 135 mg, Phase II: AK101 45 mg, Phase II: AK101 90 mg, Phase II: Placebo to AK101 |
| placebomatching placebo | Biological | Phase I: Placebo, Phase II: Placebo to AK101 |
Primary outcome
Incidence of treatment emergent adverse events (TEAEs)
Time frame: From the time of signing informed consent till Week 16 for Phase I or Week 28 for Phase II
7 secondary outcomes
Number of participants who achieved ≥ 75% reduction in Psoriasis Area and Severity Index (PASI75)
Time frame: At Week 2, 4, 8, 12, 16, 20 (Phase II), 24 (Phase II) and 28 (Phase II)
Number of participants who achieved ≥ 90% reduction in PASI (PASI90)
Time frame: At Week 2, 4, 8, 12, 16, 20 (Phase II), 24 (Phase II) and 28 (Phase II)
Change From Baseline in the Physician Global Assessment (PGA)
Time frame: At Week 2, 4, 8, 12, 16, 20 (Phase II), 24 (Phase II) and 28 (Phase II)
Number of subjects who develop detectable anti-drug antibodies (ADAs)
Time frame: From first dose till Week 16 for Phase I or Week 28 for Phase II
Area under the curve (AUC) of AK101
Time frame: From first dose till Week 16 for Phase I
Minimum observed concentration (Cmin) of AK101
Time frame: From first dose till Week 16 for Phase I or Week 28 for Phase II
Maximum observed concentration (Cmax) of AK101
Time frame: From first dose till Week 16 for Phase I or Week 28 for Phase II
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rui Chen, MD principal investigator
Peking Union Medical College Hospital
Hongzhong Jin, MD principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AK101 in people with Plaque Psoriasis, run by Akeso at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment emergent adverse events (TEAEs) (time frame: From the time of signing informed consent till Week 16 for Phase I or Week 28 for Phase II). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2025.